Minimum assay (G.C.).................................................................... 99,5 %

Identity according to Pharmacopoeias................................................ p/t.

Density at 20/20..................................................................... 1,320-1,332

Density at 25/25..................................................................... 1,318-1,322

Refractive index n 20/D........................................................... 1,423-1,425

MAX. IMPURITIES

Appearance.......................................................................................... p/t.

Non-volatile matter....................................................................... 0,002 %

Residual solvents (Ph.Eur./USP)........................................................... p/t.

Ethanol, 2-Methyl-2-Butene and volatile impurities (v/v) :

Ethanol.............................................................................................. 2,0%

2-Methyl-2-Butene.......................................................................... 0,03%

Carbon Tetrachloride.....................................................................0,001%

Trichloromethane........................................................................... 0,005%

Total of impurities other than ethanol and 2-Methyl-2-Butene..........0,1%

Acidity (as HCl)............................................................................. 0,001 %

Water (H2O)..................................................................................... 0,02 %

Free chlorine (Cl).................................................................................. p/t.

Chloride (Cl)................................................................................ 0,0003 %

Heavy metals (as Pb).................................................................. 0,0001 %

Residual metals ICP: (according to EMEA/CHMP/SWP/4446/2000)

Class 1A (Pt, Pd)........................................................................... 10 ppm

Class 1B (Ir, Rh, Ru, Os)................................................................ 10 ppm

Class 1C (Mo, Ni, Cr, V)................................................................. 25 ppm

Class 2 (Cu, Mn).......................................................................... 250 ppm

Class 3 (Fe, Zn).......................................................................... 1300 ppm